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Standard Classification for Reporting Particle Contamination and Insoluble Droplets in Water and other Pharmaceutical Fluids When Analyzed by Direct Imaging Analyzers
1.1 This classification identifies a concise code which can be used by direct imaging analyzers (DIA) for reporting counts of particle and insoluble droplet contamination in pharmaceutical and biotech fluids. The coding system includes the reporting of droplet content and particle counts in the ≥1 µm range. This classification is comparable to ISO 4406, but its requirements are not inferred.
1.2 It is valid for DIA calibrated and verified per the requirements of this document, and applies to reporting of contamination in cleaning fluids as well as process fluids.
1.3 The values stated in SI units are to be regarded as standard. No other units of measure are included in this standard.
1.4 Due to the variation of method and instrument types and resolutions, the reporting of results will include the ASTM standard used to conduct the analysis.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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